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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTIUMUSA NRLINE; DENTAL IMPLANT
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DENTIUMUSA NRLINE; DENTAL IMPLANT Back to Search Results
Model Number GFX3011S
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 02/24/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant gfx3011s was removed on (b)(6) 2020 due to a fracture of the implant 3 years and 1 month after implantation.The patient has history of cardiac disease and compromised immunity.The patient required bone augmentation for the operation.The patient has recovered without complications.
 
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Brand Name
NRLINE
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
DENTIUMUSA
6761 katella ave
cypress, ca
MDR Report Key9857395
Report Number3005503242-2020-00039
Device Sequence Number16777517
Product Code DZE
UDI-Device Identifier08809460302356
UDI-Public08809460302356
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K153268
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 03/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date09/13/2024
Device Model NumberGFX3011S
Device Catalogue NumberGFX3011S
Device Lot Number201609090037
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/16/2020
Initial Report FDA Received Date03/19/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age76 YR
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